Non-serious adverse events
|
P1A BMS1200 |
P1A BMS150 |
P1A BMS300 |
P1A BMS600 |
P1A BMS600+NIV240 |
P1A BMS300+NIV240 |
P1A BMS150+NIV240 |
P1A ALL MONO |
P1A BMS1200+NIV240 |
P1A BMS1600 |
P1B BMS1200+NIV360 |
P1B BMS150+NIV360 |
P1A ALL COMBO |
P1A BMS1600+NIV240 |
P1B BMS1200+NIV480 |
P1B BMS1600SC |
P1B ALL COMBO |
P2 PANCREATIC COMBO |
P2 NSCLC COMBO |
P2 MELANOMA COMBO |
P2 2 SCCHN COMBO |
P2 RCC COMBO |
P2 RCC MONO |
P2 RCC CROSSOVER |
P2 PROSTATE COMBO |
P2 NOT ASSIGNED MONO |
P2 NOT ASSIGNED COMBO |
P2 ALL COMBO |
ALL COMBO (P1A+P1B+P2) |
Total subjects affected by non serious adverse events
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
6 / 9 (66.67%) |
11 / 14 (78.57%) |
8 / 12 (66.67%) |
8 / 12 (66.67%) |
12 / 12 (100.00%) |
11 / 11 (100.00%) |
11 / 12 (91.67%) |
45 / 59 (76.27%) |
7 / 7 (100.00%) |
12 / 12 (100.00%) |
6 / 8 (75.00%) |
9 / 9 (100.00%) |
50 / 52 (96.15%) |
9 / 10 (90.00%) |
6 / 7 (85.71%) |
17 / 18 (94.44%) |
21 / 24 (87.50%) |
17 / 19 (89.47%) |
31 / 31 (100.00%) |
14 / 15 (93.33%) |
14 / 15 (93.33%) |
17 / 18 (94.44%) |
19 / 19 (100.00%) |
3 / 3 (100.00%) |
13 / 14 (92.86%) |
1 / 1 (100.00%) |
1 / 2 (50.00%) |
110 / 117 (94.02%) |
181 / 193 (93.78%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infected neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Neoplasm malignant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Tumour pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 11 (18.18%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
4 / 14 (28.57%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
6 / 117 (5.13%) |
9 / 193 (4.66%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
6 |
9 |
Vascular disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deep vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Flushing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
3 |
3 |
Hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
3 / 18 (16.67%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
4 |
1 |
0 |
1 |
1 |
0 |
6 |
8 |
Hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
2 / 19 (10.53%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
3 / 15 (20.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
7 / 117 (5.98%) |
8 / 193 (4.15%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
2 |
0 |
1 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
7 |
8 |
Inferior vena cava stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Lymphoedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Orthostatic hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Vena cava thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Venous thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
General disorders and administration site conditions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
4 / 59 (6.78%) |
2 / 7 (28.57%) |
2 / 12 (16.67%) |
2 / 8 (25.00%) |
2 / 9 (22.22%) |
6 / 52 (11.54%) |
3 / 10 (30.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
4 / 24 (16.67%) |
5 / 19 (26.32%) |
14 / 31 (45.16%) |
5 / 15 (33.33%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
9 / 19 (47.37%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
30 / 117 (25.64%) |
40 / 193 (20.73%) |
occurrences all number
|
0 |
1 |
0 |
1 |
0 |
0 |
1 |
4 |
3 |
2 |
2 |
2 |
7 |
3 |
0 |
1 |
4 |
6 |
19 |
6 |
1 |
2 |
10 |
0 |
2 |
0 |
2 |
38 |
49 |
Axillary pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Catheter site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Chest discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
Chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Device related thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Early satiety
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
3 / 18 (16.67%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Face oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
4 |
Facial pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Fatigue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
4 / 12 (33.33%) |
4 / 11 (36.36%) |
4 / 12 (33.33%) |
3 / 59 (5.08%) |
2 / 7 (28.57%) |
1 / 12 (8.33%) |
1 / 8 (12.50%) |
4 / 9 (44.44%) |
14 / 52 (26.92%) |
0 / 10 (0.00%) |
5 / 7 (71.43%) |
9 / 18 (50.00%) |
10 / 24 (41.67%) |
6 / 19 (31.58%) |
6 / 31 (19.35%) |
1 / 15 (6.67%) |
9 / 15 (60.00%) |
4 / 18 (22.22%) |
4 / 19 (21.05%) |
2 / 3 (66.67%) |
4 / 14 (28.57%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
32 / 117 (27.35%) |
56 / 193 (29.02%) |
occurrences all number
|
1 |
1 |
0 |
0 |
4 |
5 |
4 |
3 |
2 |
1 |
1 |
4 |
15 |
0 |
5 |
9 |
10 |
6 |
6 |
3 |
9 |
5 |
7 |
2 |
4 |
0 |
0 |
35 |
60 |
Feeling cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Gait disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
Hyperthermia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
5 |
Inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
3 / 31 (9.68%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
4 |
Influenza like illness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
2 / 12 (16.67%) |
1 / 12 (8.33%) |
2 / 12 (16.67%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
3 / 59 (5.08%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
2 |
1 |
2 |
2 |
1 |
3 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
3 |
9 |
Infusion site joint swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Injection site reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Localised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Mucosal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
3 / 117 (2.56%) |
6 / 193 (3.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
3 |
6 |
Non-cardiac chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
3 / 59 (5.08%) |
0 / 7 (0.00%) |
2 / 12 (16.67%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
2 / 18 (11.11%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
3 / 31 (9.68%) |
0 / 15 (0.00%) |
3 / 15 (20.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
11 / 193 (5.70%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
1 |
1 |
3 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
2 |
0 |
1 |
3 |
0 |
4 |
0 |
0 |
0 |
1 |
0 |
0 |
9 |
12 |
Oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Oedema peripheral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
3 / 12 (25.00%) |
5 / 11 (45.45%) |
3 / 12 (25.00%) |
1 / 59 (1.69%) |
5 / 7 (71.43%) |
0 / 12 (0.00%) |
3 / 8 (37.50%) |
2 / 9 (22.22%) |
19 / 52 (36.54%) |
3 / 10 (30.00%) |
0 / 7 (0.00%) |
4 / 18 (22.22%) |
5 / 24 (20.83%) |
5 / 19 (26.32%) |
4 / 31 (12.90%) |
3 / 15 (20.00%) |
2 / 15 (13.33%) |
2 / 18 (11.11%) |
4 / 19 (21.05%) |
1 / 3 (33.33%) |
2 / 14 (14.29%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
19 / 117 (16.24%) |
43 / 193 (22.28%) |
occurrences all number
|
0 |
1 |
0 |
0 |
3 |
5 |
3 |
1 |
5 |
0 |
4 |
2 |
19 |
3 |
0 |
5 |
6 |
5 |
4 |
3 |
2 |
2 |
4 |
1 |
2 |
1 |
0 |
19 |
44 |
Pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
2 / 10 (20.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
2 / 19 (10.53%) |
2 / 31 (6.45%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
4 / 18 (22.22%) |
2 / 19 (10.53%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
10 / 117 (8.55%) |
12 / 193 (6.22%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
1 |
0 |
2 |
2 |
2 |
0 |
4 |
2 |
1 |
0 |
0 |
0 |
11 |
13 |
Peripheral swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Pyrexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
5 / 12 (41.67%) |
1 / 59 (1.69%) |
2 / 7 (28.57%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
10 / 52 (19.23%) |
1 / 10 (10.00%) |
2 / 7 (28.57%) |
6 / 18 (33.33%) |
2 / 24 (8.33%) |
4 / 19 (21.05%) |
2 / 31 (6.45%) |
3 / 15 (20.00%) |
0 / 15 (0.00%) |
2 / 18 (11.11%) |
3 / 19 (15.79%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
12 / 117 (10.26%) |
24 / 193 (12.44%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
6 |
1 |
3 |
1 |
0 |
0 |
12 |
1 |
2 |
7 |
2 |
4 |
3 |
3 |
0 |
2 |
3 |
0 |
1 |
0 |
0 |
13 |
27 |
Xerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Immune system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contrast media allergy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Hypersensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Seasonal allergy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Reproductive system and breast disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balanoposthitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Intermenstrual bleeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Pelvic pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Testis discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Vaginal discharge
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Vaginal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Cough
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
3 / 12 (25.00%) |
1 / 11 (9.09%) |
4 / 12 (33.33%) |
3 / 59 (5.08%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
14 / 52 (26.92%) |
5 / 10 (50.00%) |
2 / 7 (28.57%) |
3 / 18 (16.67%) |
3 / 24 (12.50%) |
4 / 19 (21.05%) |
9 / 31 (29.03%) |
3 / 15 (20.00%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
22 / 117 (18.80%) |
39 / 193 (20.21%) |
occurrences all number
|
0 |
1 |
0 |
1 |
5 |
1 |
4 |
3 |
1 |
1 |
1 |
0 |
16 |
5 |
2 |
3 |
3 |
4 |
12 |
3 |
1 |
3 |
1 |
0 |
2 |
0 |
1 |
26 |
45 |
Dysphonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
2 / 12 (16.67%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
3 |
Dyspnoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
2 / 12 (16.67%) |
3 / 11 (27.27%) |
2 / 12 (16.67%) |
4 / 59 (6.78%) |
2 / 7 (28.57%) |
1 / 12 (8.33%) |
2 / 8 (25.00%) |
1 / 9 (11.11%) |
12 / 52 (23.08%) |
3 / 10 (30.00%) |
1 / 7 (14.29%) |
4 / 18 (22.22%) |
4 / 24 (16.67%) |
5 / 19 (26.32%) |
11 / 31 (35.48%) |
0 / 15 (0.00%) |
3 / 15 (20.00%) |
2 / 18 (11.11%) |
5 / 19 (26.32%) |
1 / 3 (33.33%) |
3 / 14 (21.43%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
26 / 117 (22.22%) |
42 / 193 (21.76%) |
occurrences all number
|
1 |
1 |
0 |
1 |
2 |
3 |
2 |
4 |
2 |
1 |
2 |
1 |
12 |
3 |
1 |
4 |
4 |
5 |
13 |
0 |
3 |
2 |
7 |
1 |
3 |
0 |
1 |
28 |
44 |
Dyspnoea exertional
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
3 |
Haemoptysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
Hiccups
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Hypoxia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Interstitial lung disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
Laryngeal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
5 / 52 (9.62%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
1 |
5 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
7 |
Oropharyngeal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
3 |
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
3 |
5 |
Pleuritic pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Pneumonitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
3 |
Pneumothorax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
Productive cough
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
3 / 31 (9.68%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
3 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
5 |
7 |
Pulmonary embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Respiratory tract congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Rhinitis allergic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Sinus congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Throat irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Upper respiratory tract inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
Upper-airway cough syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
3 |
Psychiatric disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anxiety
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
3 / 10 (30.00%) |
1 / 7 (14.29%) |
2 / 18 (11.11%) |
2 / 24 (8.33%) |
2 / 19 (10.53%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
6 / 117 (5.13%) |
12 / 193 (6.22%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
4 |
3 |
1 |
2 |
2 |
2 |
2 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
6 |
12 |
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
2 / 59 (3.39%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
1 |
0 |
1 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
3 |
Hallucination
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Insomnia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
3 / 12 (25.00%) |
2 / 11 (18.18%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
7 / 52 (13.46%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
13 / 193 (6.74%) |
occurrences all number
|
1 |
0 |
0 |
0 |
3 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
7 |
0 |
1 |
1 |
1 |
0 |
2 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
5 |
13 |
Restlessness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Sleep disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Product issues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Device dislocation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Investigations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Activated partial thromboplastin time prolonged
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
3 |
Alanine aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
2 / 12 (16.67%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
4 / 52 (7.69%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
3 / 19 (15.79%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
8 / 193 (4.15%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
1 |
0 |
0 |
1 |
4 |
0 |
0 |
1 |
1 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
9 |
Ammonia increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Amylase decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Amylase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
5 / 31 (16.13%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
7 / 117 (5.98%) |
11 / 193 (5.70%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
1 |
0 |
2 |
0 |
0 |
7 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
9 |
15 |
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9 (22.22%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
3 / 59 (5.08%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
5 / 19 (26.32%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
9 / 117 (7.69%) |
12 / 193 (6.22%) |
occurrences all number
|
2 |
0 |
1 |
0 |
1 |
0 |
1 |
3 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
6 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
13 |
Blood alkaline phosphatase decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
4 / 31 (12.90%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
10 / 193 (5.18%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
1 |
6 |
0 |
0 |
1 |
0 |
2 |
1 |
0 |
0 |
11 |
13 |
Blood bilirubin increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
3 / 19 (15.79%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
7 |
Blood cholesterol increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Blood creatine phosphokinase MB increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Blood creatine phosphokinase decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Blood creatine phosphokinase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
3 / 12 (25.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
6 / 193 (3.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
7 |
Blood creatinine increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
5 / 31 (16.13%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
13 / 193 (6.74%) |
occurrences all number
|
1 |
0 |
0 |
0 |
3 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
6 |
0 |
1 |
1 |
1 |
0 |
5 |
0 |
1 |
2 |
3 |
2 |
0 |
3 |
0 |
10 |
17 |
Blood glucose decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Blood iron decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Blood lactate dehydrogenase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
6 / 31 (19.35%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
9 / 193 (4.66%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
8 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
11 |
Blood pressure increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Blood thyroid stimulating hormone decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
Blood thyroid stimulating hormone increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
5 |
Blood triglycerides abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Blood triglycerides increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
4 |
4 |
Blood urea increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
4 |
4 |
Blood uric acid increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Blood urine present
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
C-reactive protein increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
Electrocardiogram T wave inversion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
6 / 31 (19.35%) |
2 / 15 (13.33%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
10 / 117 (8.55%) |
12 / 193 (6.22%) |
occurrences all number
|
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
7 |
2 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
12 |
14 |
Glomerular filtration rate decreased
|
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
Glycosylated haemoglobin increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
2 |
2 |
Haemoglobin increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
Heart rate decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
7 |
Heart rate increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Immature granulocyte count increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
International normalised ratio increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Lipase decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Lipase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
1 / 10 (10.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
8 / 31 (25.81%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
3 / 18 (16.67%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
14 / 117 (11.97%) |
19 / 193 (9.84%) |
occurrences all number
|
0 |
0 |
0 |
0 |
5 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
1 |
1 |
1 |
1 |
1 |
12 |
1 |
1 |
5 |
2 |
0 |
0 |
1 |
0 |
20 |
31 |
Liver function test increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Lymphocyte count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
4 |
0 |
0 |
0 |
1 |
0 |
5 |
5 |
Lymphocyte percentage decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Monocyte count increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Neutrophil count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Neutrophil count increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
1 |
0 |
3 |
4 |
Neutrophil percentage increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Protein total decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Red blood cell count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Red blood cell sedimentation rate decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Red blood cells urine positive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
SARS-CoV-2 test positive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Transaminases increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Tri-iodothyronine free decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Troponin I increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Urine leukocyte esterase positive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Weight decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
4 / 52 (7.69%) |
0 / 10 (0.00%) |
2 / 7 (28.57%) |
0 / 18 (0.00%) |
3 / 24 (12.50%) |
1 / 19 (5.26%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
2 / 15 (13.33%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
2 / 3 (66.67%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
9 / 117 (7.69%) |
16 / 193 (8.29%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
1 |
4 |
0 |
2 |
0 |
3 |
1 |
3 |
1 |
2 |
0 |
0 |
2 |
0 |
0 |
0 |
9 |
16 |
Weight increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
White blood cell count increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
2 |
3 |
White blood cells urine positive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
Fall
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
3 |
3 |
Incision site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Infusion related reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
1 / 12 (8.33%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
3 / 59 (5.08%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
2 / 19 (10.53%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
2 / 15 (13.33%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
6 / 117 (5.13%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
1 |
1 |
1 |
0 |
1 |
0 |
3 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
2 |
1 |
0 |
0 |
1 |
0 |
0 |
6 |
8 |
Post procedural pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Procedural nausea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Procedural pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Procedural site reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Rib fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Skin abrasion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Stoma site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Vascular access site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Vascular access site rash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Wound
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Wound dehiscence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Congenital, familial and genetic disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hydrocele
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Cardiac disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrial fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Cardiac failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
2 |
Mitral valve disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Palpitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
4 |
Sinoatrial block
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Sinus bradycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sinus tachycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Tachycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Nervous system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amnesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Aphasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Burning sensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Carpal tunnel syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Central nervous system mass
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Dizziness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
6 / 193 (3.11%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
1 |
0 |
0 |
4 |
7 |
Dizziness postural
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
2 |
2 |
Dysarthria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Dysgeusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
2 |
3 |
Headache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9 (22.22%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
3 / 12 (25.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
9 / 59 (15.25%) |
2 / 7 (28.57%) |
3 / 12 (25.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
4 / 52 (7.69%) |
1 / 10 (10.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
2 / 24 (8.33%) |
0 / 19 (0.00%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
3 / 15 (20.00%) |
3 / 18 (16.67%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
10 / 117 (8.55%) |
16 / 193 (8.29%) |
occurrences all number
|
2 |
0 |
1 |
3 |
0 |
0 |
1 |
9 |
2 |
3 |
0 |
2 |
4 |
1 |
1 |
0 |
3 |
0 |
3 |
1 |
4 |
3 |
4 |
0 |
0 |
0 |
0 |
11 |
18 |
Hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Loss of consciousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Memory impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Neuropathy peripheral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
2 / 24 (8.33%) |
0 / 19 (0.00%) |
3 / 31 (9.68%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
1 |
1 |
2 |
0 |
3 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
4 |
8 |
Ophthalmic migraine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Paraesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
3 |
4 |
Peripheral sensory neuropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
2 |
Presyncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Restless legs syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Sciatica
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Seizure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Somnolence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
4 |
Spinal cord compression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Taste disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Tremor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Blood and lymphatic system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9 (22.22%) |
1 / 14 (7.14%) |
3 / 12 (25.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
3 / 11 (27.27%) |
3 / 12 (25.00%) |
9 / 59 (15.25%) |
0 / 7 (0.00%) |
3 / 12 (25.00%) |
3 / 8 (37.50%) |
1 / 9 (11.11%) |
8 / 52 (15.38%) |
2 / 10 (20.00%) |
1 / 7 (14.29%) |
2 / 18 (11.11%) |
5 / 24 (20.83%) |
2 / 19 (10.53%) |
9 / 31 (29.03%) |
3 / 15 (20.00%) |
3 / 15 (20.00%) |
4 / 18 (22.22%) |
2 / 19 (10.53%) |
2 / 3 (66.67%) |
2 / 14 (14.29%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
25 / 117 (21.37%) |
38 / 193 (19.69%) |
occurrences all number
|
2 |
1 |
3 |
0 |
0 |
6 |
3 |
9 |
0 |
3 |
3 |
1 |
11 |
2 |
1 |
2 |
5 |
2 |
9 |
4 |
3 |
4 |
2 |
2 |
2 |
2 |
0 |
26 |
42 |
Eosinophilia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
Hyperleukocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Iron deficiency anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Leukocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Lymphopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
2 |
Splenic vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Thrombocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
4 / 31 (12.90%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
5 |
Ear and labyrinth disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Middle ear effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Middle ear inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Tinnitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Vertigo
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
Vestibular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Eye disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amaurosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Conjunctival haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Conjunctival oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Diplopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Dry eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
4 |
Eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Eye irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
3 |
Eye oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Eye pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Eyelid oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Lacrimation increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
Ocular hyperaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Periorbital oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
1 |
0 |
0 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
Vision blurred
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
2 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Visual impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Xerophthalmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Gastrointestinal disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
2 / 18 (11.11%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abdominal distension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
2 / 59 (3.39%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
4 / 52 (7.69%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
2 / 18 (11.11%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |
2 |
2 |
0 |
1 |
0 |
1 |
4 |
1 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
2 |
7 |
Abdominal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
2 / 12 (16.67%) |
1 / 12 (8.33%) |
3 / 12 (25.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
5 / 59 (8.47%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
2 / 8 (25.00%) |
1 / 9 (11.11%) |
5 / 52 (9.62%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
7 / 18 (38.89%) |
4 / 24 (16.67%) |
4 / 19 (21.05%) |
2 / 31 (6.45%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
11 / 117 (9.40%) |
20 / 193 (10.36%) |
occurrences all number
|
2 |
0 |
2 |
1 |
3 |
0 |
1 |
6 |
4 |
1 |
2 |
3 |
8 |
0 |
2 |
7 |
7 |
4 |
2 |
1 |
1 |
2 |
0 |
0 |
2 |
0 |
0 |
12 |
27 |
Abdominal pain lower
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
2 / 12 (16.67%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
3 / 19 (15.79%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
4 / 19 (21.05%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
7 / 117 (5.98%) |
11 / 193 (5.70%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
4 |
1 |
0 |
0 |
0 |
3 |
3 |
0 |
1 |
1 |
4 |
0 |
0 |
0 |
0 |
8 |
12 |
Abdominal tenderness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Anal erythema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Anal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Anal pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Aphthous ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Ascites
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
2 / 18 (11.11%) |
1 / 24 (4.17%) |
7 / 19 (36.84%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
7 / 117 (5.98%) |
10 / 193 (5.18%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
2 |
1 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
10 |
Cheilitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
2 |
Colitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Constipation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
2 / 12 (16.67%) |
2 / 12 (16.67%) |
3 / 12 (25.00%) |
1 / 11 (9.09%) |
3 / 12 (25.00%) |
4 / 59 (6.78%) |
2 / 7 (28.57%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
3 / 9 (33.33%) |
11 / 52 (21.15%) |
2 / 10 (20.00%) |
3 / 7 (42.86%) |
4 / 18 (22.22%) |
7 / 24 (29.17%) |
4 / 19 (21.05%) |
5 / 31 (16.13%) |
1 / 15 (6.67%) |
2 / 15 (13.33%) |
3 / 18 (16.67%) |
3 / 19 (15.79%) |
0 / 3 (0.00%) |
4 / 14 (28.57%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
19 / 117 (16.24%) |
37 / 193 (19.17%) |
occurrences all number
|
0 |
0 |
2 |
2 |
4 |
1 |
3 |
4 |
2 |
0 |
1 |
3 |
12 |
2 |
3 |
4 |
7 |
4 |
6 |
1 |
3 |
3 |
6 |
0 |
6 |
1 |
0 |
23 |
42 |
Dental caries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Diarrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
4 / 12 (33.33%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
1 / 11 (9.09%) |
6 / 12 (50.00%) |
6 / 59 (10.17%) |
3 / 7 (42.86%) |
1 / 12 (8.33%) |
1 / 8 (12.50%) |
2 / 9 (22.22%) |
14 / 52 (26.92%) |
2 / 10 (20.00%) |
1 / 7 (14.29%) |
2 / 18 (11.11%) |
4 / 24 (16.67%) |
1 / 19 (5.26%) |
9 / 31 (29.03%) |
4 / 15 (26.67%) |
3 / 15 (20.00%) |
7 / 18 (38.89%) |
6 / 19 (31.58%) |
2 / 3 (66.67%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
27 / 117 (23.08%) |
45 / 193 (23.32%) |
occurrences all number
|
0 |
1 |
5 |
0 |
3 |
1 |
6 |
7 |
4 |
1 |
1 |
4 |
16 |
2 |
2 |
2 |
7 |
2 |
15 |
4 |
4 |
9 |
8 |
3 |
0 |
0 |
2 |
39 |
62 |
Dry mouth
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
3 / 9 (33.33%) |
6 / 52 (11.54%) |
2 / 10 (20.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
3 / 24 (12.50%) |
1 / 19 (5.26%) |
2 / 31 (6.45%) |
2 / 15 (13.33%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
6 / 117 (5.13%) |
15 / 193 (7.77%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
1 |
0 |
0 |
3 |
7 |
3 |
0 |
0 |
3 |
1 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
16 |
Dyspepsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
2 / 24 (8.33%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
5 |
Dysphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
3 |
3 |
Epigastric discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Faeces discoloured
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Flatulence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
2 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
4 |
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Gastrointestinal hypermotility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
2 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
4 |
7 |
Gingival pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Glossitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Haemorrhoidal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
4 |
Lip blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Melaena
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Nausea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
2 / 12 (16.67%) |
3 / 12 (25.00%) |
0 / 12 (0.00%) |
7 / 11 (63.64%) |
4 / 12 (33.33%) |
6 / 59 (10.17%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
1 / 8 (12.50%) |
3 / 9 (33.33%) |
13 / 52 (25.00%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
5 / 18 (27.78%) |
4 / 24 (16.67%) |
4 / 19 (21.05%) |
4 / 31 (12.90%) |
0 / 15 (0.00%) |
2 / 15 (13.33%) |
3 / 18 (16.67%) |
2 / 19 (10.53%) |
2 / 3 (66.67%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
17 / 117 (14.53%) |
34 / 193 (17.62%) |
occurrences all number
|
0 |
0 |
2 |
4 |
0 |
8 |
4 |
7 |
1 |
1 |
2 |
5 |
15 |
2 |
0 |
5 |
7 |
4 |
4 |
0 |
2 |
3 |
3 |
2 |
3 |
0 |
0 |
18 |
40 |
Odynophagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
3 |
Oral disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Oral lichen planus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
2 / 19 (10.53%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Paraesthesia oral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Proctalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Rectal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Small intestinal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Stomatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Toothache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Vomiting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
4 / 12 (33.33%) |
2 / 12 (16.67%) |
2 / 12 (16.67%) |
5 / 11 (45.45%) |
2 / 12 (16.67%) |
6 / 59 (10.17%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
2 / 9 (22.22%) |
12 / 52 (23.08%) |
3 / 10 (30.00%) |
1 / 7 (14.29%) |
4 / 18 (22.22%) |
3 / 24 (12.50%) |
3 / 19 (15.79%) |
4 / 31 (12.90%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
3 / 19 (15.79%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
11 / 117 (9.40%) |
26 / 193 (13.47%) |
occurrences all number
|
0 |
0 |
6 |
3 |
2 |
6 |
2 |
9 |
0 |
0 |
0 |
5 |
14 |
4 |
1 |
4 |
6 |
3 |
4 |
0 |
1 |
3 |
3 |
1 |
0 |
0 |
0 |
12 |
32 |
Hepatobiliary disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bile duct stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Cholestasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Hepatic cytolysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Hypertransaminasaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Immune-mediated hepatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Portal vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alopecia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Decubitus ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Dermatitis acneiform
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
3 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
4 |
Dermatitis contact
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Dry skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
2 / 15 (13.33%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
6 / 117 (5.13%) |
10 / 193 (5.18%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
1 |
3 |
0 |
0 |
0 |
1 |
0 |
2 |
2 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
6 |
10 |
Ecchymosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Erythema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Hyperhidrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
2 / 59 (3.39%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
2 |
Lichenoid keratosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Night sweats
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
Onychoclasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Pain of skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
2 |
2 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
1 / 2 (50.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
Photosensitivity reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
2 / 14 (14.29%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
2 / 11 (18.18%) |
0 / 12 (0.00%) |
2 / 59 (3.39%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
3 / 9 (33.33%) |
5 / 52 (9.62%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
3 / 24 (12.50%) |
3 / 19 (15.79%) |
3 / 31 (9.68%) |
3 / 15 (20.00%) |
2 / 15 (13.33%) |
2 / 18 (11.11%) |
2 / 19 (10.53%) |
1 / 3 (33.33%) |
3 / 14 (21.43%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
17 / 117 (14.53%) |
25 / 193 (12.95%) |
occurrences all number
|
0 |
2 |
0 |
0 |
1 |
2 |
0 |
2 |
1 |
0 |
0 |
3 |
5 |
1 |
0 |
0 |
3 |
3 |
3 |
3 |
2 |
2 |
2 |
1 |
3 |
0 |
0 |
17 |
25 |
Rash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
2 / 7 (28.57%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
5 / 52 (9.62%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
2 / 19 (10.53%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
13 / 193 (6.74%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
7 |
2 |
0 |
0 |
0 |
2 |
1 |
1 |
1 |
2 |
2 |
0 |
1 |
0 |
0 |
8 |
15 |
Rash macular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Rash maculo-papular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
2 / 15 (13.33%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
4 |
7 |
Rash pruritic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Skin fissures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Skin fragility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Skin hyperpigmentation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Skin hypopigmentation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Skin induration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Skin lesion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Skin ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
2 |
2 |
Urticaria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
3 |
Vitiligo
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Xeroderma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Renal and urinary disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bladder spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chromaturia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
Chronic kidney disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
2 |
2 |
Dysuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
Haematuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
2 |
0 |
3 |
0 |
1 |
0 |
8 |
8 |
Hydronephrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Leukocyturia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Nocturia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Pollakiuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
4 |
Strangury
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Urinary incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Urinary retention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Endocrine disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adrenal insufficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Hyperthyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
4 |
Hypothyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 11 (18.18%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
1 / 9 (11.11%) |
5 / 52 (9.62%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
2 / 24 (8.33%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
11 / 193 (5.70%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
1 |
1 |
5 |
1 |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
5 |
12 |
Inappropriate antidiuretic hormone secretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Secondary adrenocortical insufficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9 (22.22%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
2 / 11 (18.18%) |
3 / 12 (25.00%) |
3 / 59 (5.08%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
7 / 52 (13.46%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
5 / 18 (27.78%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
4 / 31 (12.90%) |
2 / 15 (13.33%) |
2 / 15 (13.33%) |
2 / 18 (11.11%) |
4 / 19 (21.05%) |
0 / 3 (0.00%) |
3 / 14 (21.43%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
14 / 117 (11.97%) |
22 / 193 (11.40%) |
occurrences all number
|
2 |
1 |
0 |
0 |
1 |
3 |
3 |
3 |
0 |
0 |
0 |
1 |
9 |
2 |
0 |
5 |
1 |
1 |
4 |
3 |
2 |
2 |
6 |
0 |
4 |
1 |
0 |
16 |
26 |
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Back pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
2 / 12 (16.67%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
2 / 8 (25.00%) |
3 / 9 (33.33%) |
8 / 52 (15.38%) |
4 / 10 (40.00%) |
2 / 7 (28.57%) |
2 / 18 (11.11%) |
7 / 24 (29.17%) |
1 / 19 (5.26%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
3 / 19 (15.79%) |
2 / 3 (66.67%) |
2 / 14 (14.29%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
12 / 117 (10.26%) |
27 / 193 (13.99%) |
occurrences all number
|
0 |
0 |
0 |
1 |
2 |
0 |
1 |
1 |
1 |
0 |
2 |
4 |
8 |
4 |
2 |
2 |
8 |
1 |
4 |
1 |
1 |
2 |
3 |
2 |
2 |
1 |
0 |
13 |
29 |
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
2 |
4 |
Clubbing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Coccydynia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Flank pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
2 / 18 (11.11%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
3 |
0 |
0 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
5 |
Joint range of motion decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
2 |
Joint stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Joint swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
2 |
Limb discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Mobility decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Muscle spasms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 12 (16.67%) |
0 / 11 (0.00%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
5 / 52 (9.62%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
3 / 19 (15.79%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
9 / 193 (4.66%) |
occurrences all number
|
0 |
0 |
0 |
0 |
2 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
3 |
0 |
2 |
0 |
0 |
5 |
10 |
Muscular weakness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
2 |
0 |
0 |
4 |
7 |
Musculoskeletal chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
3 / 12 (25.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
1 / 19 (5.26%) |
3 / 31 (9.68%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
0 |
0 |
1 |
3 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
3 |
0 |
0 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
8 |
Musculoskeletal discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Musculoskeletal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
5 |
Musculoskeletal stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
2 / 11 (18.18%) |
0 / 12 (0.00%) |
2 / 59 (3.39%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
3 / 52 (5.77%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
2 / 19 (10.53%) |
2 / 31 (6.45%) |
4 / 15 (26.67%) |
2 / 15 (13.33%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
13 / 117 (11.11%) |
17 / 193 (8.81%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
2 |
0 |
2 |
0 |
1 |
0 |
1 |
3 |
1 |
0 |
0 |
1 |
2 |
2 |
4 |
2 |
1 |
0 |
0 |
2 |
0 |
0 |
13 |
17 |
Myopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Neck pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
6 |
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Pain in extremity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
2 / 14 (14.29%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
2 / 59 (3.39%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
2 / 18 (11.11%) |
0 / 24 (0.00%) |
3 / 19 (15.79%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
3 / 18 (16.67%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
11 / 117 (9.40%) |
15 / 193 (7.77%) |
occurrences all number
|
0 |
2 |
0 |
0 |
1 |
1 |
1 |
2 |
1 |
0 |
0 |
0 |
4 |
0 |
0 |
2 |
0 |
3 |
3 |
1 |
1 |
3 |
0 |
0 |
0 |
2 |
0 |
11 |
15 |
Sarcopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Trismus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Infections and infestations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bacteraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
2 / 10 (20.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
4 |
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
Ear infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Escherichia infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Fungal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Furuncle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Herpes virus infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Localised infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Mucosal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Nail infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Nasal herpes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Nasopharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
4 |
Onychomycosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
1 |
1 |
Oral herpes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Oral infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
Otitis externa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Periodontitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Pharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
3 / 52 (5.77%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
4 / 15 (26.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
9 |
Pneumonia aspiration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Propionibacterium infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
Purulent discharge
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Renal abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Respiratory tract infection viral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
1 |
Rhinitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
2 / 31 (6.45%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
2 / 19 (10.53%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
4 / 193 (2.07%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
2 |
4 |
Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9 (11.11%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sinusitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
0 / 193 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Skin infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Tooth abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Tooth infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Upper respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
3 / 52 (5.77%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
0 / 18 (0.00%) |
2 / 24 (8.33%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
3 |
0 |
1 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
3 |
8 |
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
2 / 12 (16.67%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
4 / 18 (22.22%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
7 / 117 (5.98%) |
12 / 193 (6.22%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
1 |
0 |
4 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
4 |
2 |
0 |
1 |
0 |
0 |
7 |
12 |
Vaginal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
1 / 9 (11.11%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
1 / 24 (4.17%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Viral infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
2 / 193 (1.04%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
Wound infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
1 / 117 (0.85%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Metabolism and nutrition disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
2 / 12 (16.67%) |
1 / 12 (8.33%) |
2 / 12 (16.67%) |
1 / 11 (9.09%) |
6 / 12 (50.00%) |
3 / 59 (5.08%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
3 / 9 (33.33%) |
11 / 52 (21.15%) |
2 / 10 (20.00%) |
0 / 7 (0.00%) |
6 / 18 (33.33%) |
3 / 24 (12.50%) |
6 / 19 (31.58%) |
5 / 31 (16.13%) |
1 / 15 (6.67%) |
3 / 15 (20.00%) |
3 / 18 (16.67%) |
5 / 19 (26.32%) |
2 / 3 (66.67%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
21 / 117 (17.95%) |
35 / 193 (18.13%) |
occurrences all number
|
0 |
0 |
2 |
1 |
2 |
1 |
6 |
3 |
0 |
0 |
0 |
4 |
11 |
2 |
0 |
6 |
4 |
6 |
6 |
1 |
3 |
3 |
7 |
2 |
1 |
0 |
0 |
22 |
37 |
Dehydration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
2 / 7 (28.57%) |
2 / 18 (11.11%) |
2 / 24 (8.33%) |
2 / 19 (10.53%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
0 |
1 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
4 |
8 |
Folate deficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
2 / 18 (11.11%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
Glucose tolerance impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
0 / 31 (0.00%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
0 / 117 (0.00%) |
1 / 193 (0.52%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
Hypercalcaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
1 / 14 (7.14%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
1 / 9 (11.11%) |
2 / 52 (3.85%) |
1 / 10 (10.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
3 / 24 (12.50%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
10 / 193 (5.18%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
1 |
1 |
2 |
1 |
1 |
1 |
3 |
1 |
1 |
0 |
2 |
2 |
0 |
1 |
0 |
0 |
0 |
7 |
12 |
Hypercholesterolaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
8 / 31 (25.81%) |
2 / 15 (13.33%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
11 / 117 (9.40%) |
11 / 193 (5.70%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
13 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
16 |
16 |
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
1 / 10 (10.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
8 / 31 (25.81%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
1 / 1 (100.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
9 / 193 (4.66%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
4 |
4 |
0 |
1 |
0 |
0 |
12 |
0 |
0 |
0 |
1 |
0 |
0 |
3 |
0 |
12 |
16 |
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
5 / 31 (16.13%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
7 / 193 (3.63%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
5 |
7 |
Hypertriglyceridaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
3 / 31 (9.68%) |
1 / 15 (6.67%) |
1 / 15 (6.67%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
5 / 117 (4.27%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
8 |
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
0 / 52 (0.00%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
7 / 31 (22.58%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
8 / 117 (6.84%) |
8 / 193 (4.15%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
12 |
12 |
Hypoalbuminaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
4 / 52 (7.69%) |
2 / 10 (20.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
6 / 31 (19.35%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
1 / 3 (33.33%) |
2 / 14 (14.29%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
12 / 117 (10.26%) |
16 / 193 (8.29%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
5 |
3 |
0 |
0 |
0 |
1 |
7 |
3 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
15 |
20 |
Hypocalcaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
1 / 11 (9.09%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
3 / 117 (2.56%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
5 |
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
1 / 15 (6.67%) |
2 / 15 (13.33%) |
0 / 18 (0.00%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
4 / 117 (3.42%) |
5 / 193 (2.59%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
7 |
Hypomagnesaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
2 / 11 (18.18%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
1 / 7 (14.29%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
6 / 52 (11.54%) |
2 / 10 (20.00%) |
0 / 7 (0.00%) |
0 / 18 (0.00%) |
0 / 24 (0.00%) |
1 / 19 (5.26%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
2 / 15 (13.33%) |
1 / 18 (5.56%) |
1 / 19 (5.26%) |
0 / 3 (0.00%) |
1 / 14 (7.14%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
6 / 117 (5.13%) |
12 / 193 (6.22%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
1 |
1 |
0 |
0 |
6 |
2 |
0 |
0 |
0 |
1 |
1 |
0 |
2 |
1 |
1 |
0 |
1 |
0 |
0 |
6 |
12 |
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
1 / 12 (8.33%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
1 / 59 (1.69%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
1 / 8 (12.50%) |
0 / 9 (0.00%) |
2 / 52 (3.85%) |
0 / 10 (0.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
2 / 24 (8.33%) |
4 / 19 (21.05%) |
6 / 31 (19.35%) |
1 / 15 (6.67%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
12 / 117 (10.26%) |
16 / 193 (8.29%) |
occurrences all number
|
0 |
0 |
1 |
0 |
1 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
2 |
0 |
1 |
1 |
2 |
4 |
6 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
12 |
16 |
Hypophosphataemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
1 / 12 (8.33%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
0 / 12 (0.00%) |
2 / 59 (3.39%) |
0 / 7 (0.00%) |
1 / 12 (8.33%) |
0 / 8 (0.00%) |
2 / 9 (22.22%) |
2 / 52 (3.85%) |
2 / 10 (20.00%) |
1 / 7 (14.29%) |
1 / 18 (5.56%) |
3 / 24 (12.50%) |
2 / 19 (10.53%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
1 / 15 (6.67%) |
2 / 18 (11.11%) |
3 / 19 (15.79%) |
1 / 3 (33.33%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
7 / 117 (5.98%) |
12 / 193 (6.22%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
0 |
2 |
2 |
2 |
1 |
1 |
3 |
2 |
1 |
0 |
1 |
2 |
4 |
2 |
0 |
0 |
0 |
8 |
13 |
Iron deficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9 (0.00%) |
0 / 14 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 12 (0.00%) |
0 / 11 (0.00%) |
1 / 12 (8.33%) |
0 / 59 (0.00%) |
0 / 7 (0.00%) |
0 / 12 (0.00%) |
0 / 8 (0.00%) |
0 / 9 (0.00%) |
1 / 52 (1.92%) |
0 / 10 (0.00%) |
0 / 7 (0.00%) |
1 / 18 (5.56%) |
0 / 24 (0.00%) |
0 / 19 (0.00%) |
1 / 31 (3.23%) |
0 / 15 (0.00%) |
0 / 15 (0.00%) |
1 / 18 (5.56%) |
0 / 19 (0.00%) |
0 / 3 (0.00%) |
0 / 14 (0.00%) |
0 / 1 (0.00%) |
0 / 2 (0.00%) |
2 / 117 (1.71%) |
3 / 193 (1.55%) |
occurrences all number
|
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |